FDA Votes to Keep Warning on Chantix

Despite the protests of the multi-billion dollar pharmaceutical company Pfizer, the FDA have voted to keep the black box warnings on the smoking cessation drug Chantix, known as Champix in Europe.

Only one person of the 11 panel members made up of  the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted to remove the black box warning.

Despite the evidence showing an increase in suicide, aggression and other bizarre side effects  Pfizer's Christopher Wohlberg, MD, PhD, said  "We think the available evidence is inconsistent with a boxed warning."

The panel disagreed and warnings will remain in place.

Below is a video presented to the committee meeting by patient advocate Kim Witczak.

These are actual patient testimonies - something Pfizer should pay heed to.

Bob Fiddaman

Back Stories

Pfizer enters final settlements in 660 Chantix lawsuits

Chantix Class-Action Plaintiff Is Former Pfizer Employee

Passenger Safety - The Champix Scandal

Chantix Dangers

The following is a message from Kim Witczak, a drug safety advocate who is testifying in front of the FDA soon on behalf of users of Chantix who have experienced severe side effects - the FDA are considering removing the black box warning that comes with Chantix.

For those that don't know Chantix is a smoking cessation drug and has a dark history with regard to suicidal and homicidal acts. It's maker, Pfizer, have made many settlements out of court. Chantix is also known as Champix, it's generic name being varenicline.

In 2008 the Federal Aviation Administration [FAA] took the unusual step of banning the use of Chantix after it learned the anti-smoking medicine might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately.

The FAA took this action one week after a medical safety group, the Institute for Safe Medication Practices, released the results of a study that found evidence for the occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix.

Chantix was the subject of a freedom of information request I made back in April 2010. I had learned that the Federal Aviation Administration [FAA] had changed their policy regarding pilots being allowed to operate aircraft whilst under the influence of SSRi-type medication. The full 58 page document sent to me can be read here.

Here's a message from Kim.

You can contact her with your story via the email address at the end of her message.

--

Have you or anyone you know taken Chantix to quit smoking?

The psychiatric side effects of Chantix are moving back to center stage. Later this month the FDA will be holding hearings to decide whether or not to remove or reduce the black box warnings on Chantix.

Chantix came under fire after reports of hostility, suicide, suicide attempts and other psychiatric disturbances such as aggression and nightmares. In 2009 FDA required a "black box" warning (most serious of warnings) on the drug, to alert patients and doctors to the risk of psychiatric side effects.

Now, they are saying after further review the data from recent studies found little or no evidence of psychiatric problems. What gives?

Last year Pfizer settled the majority of its 2,700 lawsuits against it for $275M. Chantix had global sales of $648 million last year. That was down about 26 percent from the drug's peak sales of $883 million in 2007.

How you can help???

In preparation for my testimony at the FDA hearing, I will be representing the voice of people who have experienced psychiatric side effects from taking this drug. If you have a personal story and are willing to share it, please let me know. We need real life experiences vs just what Pfizer shares.

As you many of you know, I have been working on drug safety issues since my husband took his own life after being given antidepressant Zoloft for insomnia in 2003. (At the time there were no warnings on these drugs.) There are many parallels between the narratives surrounding antidepressants and Chantix. There are many, including myself, who believe that this is the first step in undoing the black box warnings for antidepressants.

Warnings are there for a reason. It gives information about a drug's potential risks and what to look for if you or loved one are taking it. You never know if you or your loved one may be the small % of risk. But that small % could be your 100%.

If you have a Chantix story, please share.

Email - Info@woodymatters.com


Bob Fiddaman.

MHRA CEO, Paxil and Suicide

Much has been said about the conflict of interest between the British drug regulator, (MHRA), and GlaxoSmithKline. It's obvious to those who know the history of GSK and the MHRA that there is a huge conflict of interest that just cannot be ignored and while such a conflict exists patients will not be safeguarded from the likes of Paxil, a drug marketed and manufactured by GlaxoSmithKline.

I've met with the MHRA are a number of occasions, at one stage I offered to help them with their out of date and deeply flawed yellow card reporting system, a system where adverse events are collected and...well, basically nothing is ever done.

Communications between me and their then CEO, Kent Woods, broke down due to his refusal to acknowledge that Paxil, known as Seroxat in the UK, should be classed as a teratogen. A teratogen is an agent or factor that causes malformation of an embryo.

Much of my communication with the MHRA is in my book, 'The evidence however, is clear, the Seroxat scandal' [1]

In 2013 Kent Woods retired and the MHRA appointed Dr Ian Hudson (pic above) as their new CEO.

Hudson, who after leaving Glaxo in 2001, became the MHRA's Licensing Director, responsible for overseeing the benefits and risks of drugs before they hit the market.

Yup, the man in charge of the agency who have the job of keeping tabs on the drugs you and I take is a former employee of GSK - then known as SmithKline Beecham.

Hudson, whilst working for GSK, was a witness for the defence [GSK] during the Tobin v SmithKline Beecham Pharmaceuticals. In 1998 Donald Schell was put on Paxil [Seroxat]. Forty-eight hours later he put three bullets from two different guns through his wife's head, as well as through his daughter's head then through his granddaughter's head before shooting himself through the head.

Hudson's deposition has been online for sometime in text form, a copy of it can be viewed here.

Sadly, it's been difficult trying to obtain the actual video footage of Hudson being depoed by US attorneys representing Tobin.

We do, however, have a small segment of his video deposition.

In 2002 Investigative journalist Shelley Jofre launched her first installment into the whole Paxil debacle. BBC Panorama's 'The Secrets of Seroxat' was aired and it prompted over 67,000 calls and emails from concerned consumers.

During the documentary Shelley touched on the case of  Donald Schell. The footage in the documentary revealed part of Dr Ian Hudson's video deposition. Remember, at the time, Hudson was a GSK employee.

Watch.... (Hudson was depoed in 2000)

**If the video starts with Andy Vickery talking then click the bar to end of video then press play**

In 2008 the MHRA concluded a four year investigation of GlaxoSmithKline, the crux of which was to find out whether GlaxoSmithKline withheld paediatric safety data pertaining to suicide related to its antidepressant Seroxat. They decided not proceed to criminal prosecution. It's unknown if they interviewed their own Dr Ian Hudson during their four year investigation. [2]

As I said, Dr Ian Hudson is now the Chief Executive of the MHRA, the agency that purportedly protects British consumers of prescription drugs.

I don't know about you but this doesn't really fill me with a sense that I am being protected from dangerous drugs. Does it you?

All four Paxil videos will soon be available in their entirety on Rxisk. 

Bob Fiddaman

[1] 'The evidence however, is clear, the Seroxat scandal' [US] [UK]

[2] GSK investigation concludes [Link]

Antidepressant Aggression, the MHRA Perspective

Last month I wrote a piece entitled, 'Antidepressants: The Power To Harm' which, basically, highlighted the Japanese drug regulator and the Japanese Ministry of Health, Labour and Welfare. [MHLW]

A 2009 review of antidepressants in Japan [1] resulted in MHLW issuing an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

They found that causality between SSRi antidepressants and harmful behavior to others could not be denied in 2 cases of reported adverse reactions associated with fluvoxamine maleate and 2 cases of reported adverse reactions associated with paroxetine hydrochloride hydrate. For the remaining 35 cases of adverse reactions, causality between the drug and adverse reactions was considered unknown.

After reading this review I wrote to the British drug regulator, the MHRA.

Dear Sir/Madam,

I would like to know if the MHRA have any information, be it by study or review, regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury). 

Please state if any alerts to patients and their families have ever been sent out regarding this issue.

Please state if any revision to package inserts have been made regarding this issue.

The MHRA have now answered and, it has to be said, it would appear that patient welfare is far higher on the list in Japan than it is in the UK.

First off, their cover letter to me.

I like the final paragraph...

"The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder."

I'm not going to bother asking the MHRA if I am allowed to republish, what I deem as, important safety information regarding SSRi use and aggression. They've used this threat before with me, see 'The evidence, however, is clear, the Seroxat scandal'. [2]


The MHRA have provided me with 30 pages of information with regard to the question I put to them, much of which is redacted [blacked out]

It would be pointless to post all 30 pages but those wishing to scrutinize can request a copy from me by emailing me.

Some points...

The information sent to me from the MHRA was taken from meetings that occurred between the years 1996 and 2001.

Contrast that to the Japanese information on SSRis and aggression. Their information is more up to date, in fact it is 8 years more up to date than what the MHRA have given me.

The MHRA, or the data they sent me, points to two SSRis causing aggression. Fluoxetine and Paroxetine, namely, Prozac and Seroxat (Paxil)

Remarkably these findings of aggression with Prozac and Seroxat use have been played down by claiming that the reporting rates of aggression increased when stories started appearing in the media. The MHRA do not balance this claim, for instance, (i) the reporting rates may have increased because patients may not have known that the MHRA actually collected such reports and (ii) consumers may have attributed their aggression and suicidal thinking to their illness, opposed to it being a possible adverse reaction to the drug they were taking.

Page 23 of the 30 page document they sent me is quite telling. [Fig 1]

Fig 1

So, when there is a clear sign that aggression is occurring during Prozac and/or Seroxat treatment it has, if you believe the above, nothing to do with the drug/s, it is possibly a "separate event from the underlying illness" or it's "part of a discontinuation syndrome", or maybe the aggression has appeared because of the removal of the therapeutic benefits of the drug.

Once again, the suggestion of media reports on antidepressants and the suicide link are mentioned. It's almost as if they [the committees who reviewed the aggression link in SSRi use] are putting something in place. Rather than look at the blindingly obvious problem they chose to deflect and lay the blame on intense media reporting.

Now, contrast this stance with those of the Japanese.

2009:

The Japanese Ministry of Health, Labour and Welfare issued an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

The above was based on a review where they found an association with SSRis and aggression.

No pussy-footing around, no blaming the media, no blaming a discontinuation syndrome or no blaming the underlying illness causing the aggression. Moreover, the  Japanese Ministry of Health, Labour and Welfare sent an alert out to patients and their families about their findings.

I don't know about you but if one regulator flags a warning about patients becoming aggressive on antidepressants then other regulators around the world should act promptly.

Judging by the material sent to me by the MHRA, they put the SSRi aggression link to bed in 2002 and have done nothing more about it since then.

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.

Oh really?



Bob Fiddaman


1. 2009 Selective Serotonin Reuptake Inhibitors and Aggression [Japanese Review] [Link]
2. The evidence, however, is clear, the Seroxat scandal. [Link]

Antidepressants: The Power To Harm

Much has been said about the suicide link with antidepressant use. I think we should accept that antidepressants can induce suicide given that the manufacturers and regulators have now admitted this one small fact that they previously [conveniently] omitted.

If a person can kill themselves due to an adverse reaction to a drug then could they also harm others?

In cases of homicide the antidepressant defence has been used many times, "My client was under the influence of an antidepressant and had homicidal thoughts your Honour".

Those that use such a defence are ridiculed because those that manufacture these types of drugs refuse to admit that their products can induce acts of homicide in those who take them.

Two high profile cases involve three SSRi type drugs, namely, Citalopram [known as Celexa in the US] and Seroxat [known as Paxil in the US] and Prozac.



Shane Clancy (22) drove to the quiet residential area of Cuala Grove in Bray where he unleashed an attack of psychotic proportions on his ex-girlfriend and her new boyfriend. Sebastian Creane. Creane's brother, Dylan, was stabbed nine times when he came to his aid.

The following afternoon, August 16, 2009, Shane Clancy's body was found in the back garden at Cuala Grove. He had stabbed himself 19 times.

The inquest into Shane's death returned an open verdict. The jury wasn't satisfied that he had intended to take his own life. Shane had toxic levels of citalopram, in his system. [More here]

David Crespi was alone with his twin daughters when he stabbed them to death, then called 911 to report the murder. The cocktail of drugs that his wife said pushed him over the edge was Prozac, Ambien, Trazadone and Lunesta. He'd been taking them for one to three weeks.

David Crespi entered guilty plea came to avoid the death penalty, but it led to a life sentence with no chance of parole. [More here]



There are those that refuse to accept that the antidepressants in the above cases played any part in the decisions of those who carried out these violent acts, opting instead to blame the 'mental illness'.

What if evidence could be provided, would it ease the pain of those left behind to pick up the pieces?

Exactly who are the victims here?

Those who were killed, the loved ones of those who were killed or those who carried out the homicide?

Well, all of them.

A 2009 review of antidepressants in Japan has been flying under the radar for some time and it was only by chance that I happened to find it via the Japanese Medicine Regulatory website.

The Japanese Ministry of Health, Labour and Welfare [MHLW]  reviewed reported adverse reactions of aggression, etc. including harmful behavior to others (including injury) associated with SSRIs or SNRIs.

MHLW issued an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

Here's what they found...

"After a careful review of the 39 cases of harmful behavior to others including injury (including 4 potential episodes associated with milnacipran hydrochloride that could have resulted in harmful behavior) identified from the clinical course, causality between the drug and harmful behavior to others could not be denied in 2 cases of reported adverse reactions associated with fluvoxamine maleate and 2 cases of reported adverse reactions associated with paroxetine hydrochloride hydrate. For the remaining 35 cases of adverse reactions, causality between the drug and adverse reactions was considered unknown.  

"In light of the above findings and discussions amongst specialists, it is considered necessary to add the following precautionary statements to the “Important Precautions” section of package inserts: 1) Episodes of anxiety, irritation, excitement, panic attack, irritability, hostility, aggression, and impulsivity have been reported; 2) In patients with these symptoms or behavior, exacerbation of underlying disease, harmful behavior to others, etc. have been reported, though causality with the drugs is not clear; 3) Patients should be carefully monitored for changes in their clinical condition; 4) Patients’ families should be given full information on risks associated with changes in behavior such as excitement, aggression, irritability, etc., and an exacerbation of underlying disease, and be instructed to keep in close contact with the physician."

I wrote to the British drug regulator, the MHRA and asked them the following...

Dear Sir/Madam,

I would like to know if the MHRA have any information, be it by study or review, regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury).

Please state if any alerts to patients and their families have ever been sent out regarding this issue.

Please state if any revision to package inserts have been made regarding this issue.

The MHRA have deemed that my query falls under the Freedom of Information Act and that I should receive a reply within 20 working days.

I'll keep you updated of any reply they send me.

Next time you read about a gun slaying in an American school it may be worth taking this Japanese review into account.

Next time you read of a murder carried out by someone who, just like the above three cases, were your normal, average, hard working male... then take the Japanese review into account.

Here's a recent one that raises all the red flags, for me at least.

The review by the  Japanese Ministry of Health, Labour and Welfare can be downloaded here.

Bob Fiddaman.

How Do You Like Your Fish... Battered?

An old story yet one that is worthy to resurface every now and again.

It concerns Prozac [fluoxetine], the antidepressant drug that British regulators recognise as being safe in the pediatric population.

Whilst other SSRi's have been flagged for use in children the MHRA see no problem at all in prescribing it to those under the age of 18, in fact, in 2005 the MHRA were still advising health care practitioners to prescribe Prozac to children despite a strong recommendation from the European Medicines Agency that it increases susceptibility to suicidal feelings and aggression. [1]

Their stance seems rather bizarre given that, in 2011, they found that Prozac may cause a small increase in the risk of heart defects in the  unborn child.

As we know, antidepressants can cause feelings of aggression which, in turn, can lead to thoughts of self-harm and even suicide. The evidence is well documented.

Quite why the MHRA choose to bury their heads in the sand when it comes to Prozac baffles me.

In the latest edition of Aquatic Toxicology, fish exposed to the antidepressant Fluoxetine exhibited a range of altered mating behaviours, repetitive behaviour and aggression towards female fish.

The authors of the study set up a series of experiments exposing a freshwater fish (Fathead Minnow) to a range of Prozac concentrations. Following exposure for 4 weeks the authors observed and recorded a range of behavioural changes among male and female fish relating to reproduction, mating, general activity and aggression. 

"With increased aggression, in the highest level of concentration, female survivorship was only 33% compared to the other exposures that had a survivorship of 77–87.5%. The females that died had visible bruising and tissue damage," according to Rebecca Klaper.

It would, as consumers, be beneficial if we could compare data to see how the MHRA arrived at their decision to approve Prozac - here's where it takes a rather conspiratorial twist.

Peter Gotzsche, co-founder of the Cochrane Collaboration, submitted a request to the MHRA to see the Prozac data. Bizarrely, the MHRA informed him that they had shredded the vast majority of the clinical evidence it held on the treatment and the Prozac.

Convenient huh?

So what of the fish study above, will the MHRA look into it?

I doubt it, in fact anytime I have contacted the MHRA to air my views on antidepressant use in children I have been met with the same cut and paste answer from their pharmacovigilance team, "The findings of the CSM Expert Working Group on the safety of selective serotonin reuptake inhibitor antidepressants...blah, blah, blah, bloody blah".

With fish being exposed to Prozac and aggression being noted one would think that this would sound alarm bells at the MHRA - to be honest they are too busy back-slapping one another by publishing letters on their website that acknowledges just how great they are at protecting the British public.

Their latest being a letter showing how, after an MHRA investigation, two men were sentenced to 8 months imprisonment [suspended for two years] for multiple importations of counterfeit condoms.

John Wilkinson, the MHRA’s Director of Medical Devices, said:

“It’s vital that people buy condoms from well-known reputable retailers and pharmacies. People should also be aware that if they buy condoms from illicit websites there is no guarantee that the product that arrives will be safe to use or of good quality.

“Counterfeit condoms look real but they are badly made and anyone using one has a higher risk of catching a sexually transmitted disease or having an unwanted pregnancy.

Heaven forbid we have unwanted pregnancies in the UK...then again, more kids = more Prozac [potentially]

So, while the MHRA are covering themselves in garlands for halting the sale of dodgy raincoats, they continue to allow drugs, that make fish aggressive, to be prescribed to children.

Way to go MHRA!

The MHRA are wholly funded by the pharmaceutical industry. Their CEO is Dr Ian Hudson. No surprise that he used to be World Safety Officer at SmithKline Beecham [now GlaxoSmithKline]

Here's Hudson in action.

No fish were harmed in the making of this video.

Bob Fiddaman




[1] UK regulator backs Prozac for children

Former Glaxo Safety Officer Becomes Head of MHRA

Ex Glaxo Employee Ian Hudson. Now in charge of  the safety and well-being of the British public.

Former Glaxo [then SmithKline Beecham] World Safety Officer Director Dr Ian Hudson has took over the role of Chief Executive at the MHRA.

Hudson, who after leaving Glaxo in 2001, became the MHRA's Licensing Director, responsible for overseeing the benefits and risks of drugs before they hit the market.

It is unknown why Former MHRA chief, Kent Woods, whom I've had much correspondence with over the years, retired.

Hudson, whilst working for GSK, was a witness for the defence [GSK] during the Tobin v SmithKline Beecham Pharmaceuticals. Donald Schell was put on Paxil [Seroxat]. Forty-eight hours later he put three bullets from two different guns through his wife's head, as well as through his daughter's head then through his granddaughter's head before shooting himself through the head.

Hudson was appointed GSK's World Safety Officer in 1999. His department was responsible for adverse events that were sent in by health professionals and members of the public.

Whilst under oath Hudson told Andy Vickery, attorney for Tobin, about his role in reviewing the link between Paxil and aggression.

"We reviewed the topic of aggression last year. At that time we said that we would keep aggression under review.  In addition, there was considerable noise in the media earlier this year about Fluoxetine.  So having said that we would keep this topic under review, we rereviewed this topic this year and it was also prompted by considerable concern being expressed, considerable noise being expressed in the media.  There were a series of articles in the "Guardian". [British Newspaper]

Hudson was then asked by Vickery what he intended to do with the report once it was finalised, adding; Do you intend to submit it to any governmental agency?

Hudson replied:

"If a Government agency requests information on aggression and Paroxetine, we would, but we do not intend to proactively send it to them at this stage.  This was an internal review. We do many internal reviews on many topics."

This doesn't really install confidence in informed consent. If Hudson was back then stating that his findings would not be reported to the drug regulator then one can only assume that he still holds the belief that pharmaceutical companies are entitled to hold on to information that could endanger the public.

Later in the deposition Andy Vickery put the following to Ian Hudson:

"Dr. Hudson, are you aware of the body of literature concerning the relationship between serotonin and suicide?"

Hudson replied with...

"In general.  I've seen some summary information on that.  I've not reviewed that information in detail.  I would, again, delegate that to people within my department and also other psychiatrists within the company who are more closely involved in Paroxetine then I am, people such as Dr. Wheadon."

Pushing Hudson for an answer Vickery then asked...

"Let me just ask you this:  Do you know whether or not there is any association between levels of serotonin or the serotonin metabolite 5-HIAA and suicidal behavior?"

Hudson answered...

Yes, I believe there is a correlation. I have seen in the literature summary
information that implies that there is a correlation between low levels of serotonin or 5-HIAA in patients' suicidal activity.


Vickery later asked Hudson:

"Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?"

Hudson answered:

"I have seen no evidence to suggest that at all."



Hudson's deposition can be viewed in full here.


Now Ian Hudson is the head honcho at the MHRA. If you take the time to read the complete deposition of Hudson you will see how he [whether under instruction or not] clearly deflects the blame of suicide and aggression onto other 'factors' rather than implicating Paxil.

And now this guy is in charge of regulating medicines in the UK. Do you think his presence will alter the MHRA's stance on the safety and efficacy of SSRi type medications?

Well, I have seen no evidence to suggest that at all.


Bob Fiddaman

First do no harm... providing it's no longer than 8 minutes

Dr Bhamjee, caused controversy back in 2011 when he called on the Irish Government to add lithium salts to the public water

Dr. Moosajee Bhamjee, a soon to be retired psychiatrist from Ireland, showed exactly why the profession of psychiatry needs to take a long, hard look at itself when he was a guest on the George Hook radio show in Ireland on Thursday [11 April]

Hook had been contacted by Irish blogger, Leonie Fennell regarding a GP he had interviewed a week previously on his show.

The GP, Dr. Ciara Kelly, offered her opinion to a recent article that had appeared in the Irish press [Irish Examiner] that highlighted how GP's handed out antidepressant medication at the drop of a coin. An undercover journalism student, Niamh Drohan, had approached 7 GP's in Ireland and told them she was suffering from stress and anxiety problems from her final year in college. On each visit a prescription for an antidepressant was written for Drohan. Her article ‘Depressing Truth about Treating Depression In The Young’ can be viewed here. Fennell gives her take on it here.

Hook's interview with Ciara Kelly enraged Fennell so much that she emailed the show to set the record straight. Kelly had claimed , during the course of her interview with Hook, that “the drugs themselves are not dangerous, they’re not addictive, they’re not even dangerous at high levels of overdose.”

Fennell's son, Shane, took 39 Cipramil in 17 days and his toxicology report showed a ‘toxic to fatal’ amount in his system. On the 17th day Shane, under the influence of the antidepressant citalopram, killed himself and another man. Podcast with Leonie Fennell here goes into more detail.

Fennell, along with antidepressant expert Prof. David Healy, were invited by Hook to offer their opinion as was Dr. Moosajee Bhamjee.

The interview [below] is interesting in as much that Bhamjee argues that in his 40 years as a healthcare professional he has never seen any patient who has experienced aggressiveness on these types of drugs. He also argues that Dr's only get an 8 minute slot to determine if someone is mentally ill and needs prescription medication. And there I was thinking that the Hippocratic oath taken by Dr's carried no disclaimers!


Bhamjee, caused controversy back in 2011 when he called on the Irish Government to add lithium salts to the public water supply in a bid to lower the suicide rate and depression among the general population.

Anyway... here's the debate from the Hook show.

Podcast Powered By Podbean

If you are having trouble with the audio player then the audio can be downloaded direct to your computer by right clicking and 'save as' HERE

Leonie Fennell's blog

Bob Fiddaman

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Paxil [Seroxat] Withdrawal

Anger, aggression belligerent, irrational, self-harm, suicidal, weight gain, personality change, strange behaviour.

All of the above became apparent during Paxil increase and withdrawal.

Paxil is the US brand name for paroxetine.

It is known as Seroxat in the UK and Europe.

Seroxat is marketed and sold by GlaxoSmithKline.

GlaxoSmithKline deny allegations that Seroxat has caused a significant amount of litigants withdrawal problems.

Now...

...watch and learn...

Related


GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money


MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"
 
MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA In Buck-Passing Specialist Cahoots

SEROXAT/PAXIL WITHDRAWAL GUIDANCE - FIDDAMAN 2011



Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

"Severe Psychiatric Symptoms Associated With Paroxetine Withdrawal" - The Lancet, 1995

Hey Glaxo...and your highly paid Devil advocates. Whilst in Toronto I picked up a disc full of Paxil articles, studies, case reports etc. I have enough here to keep me occupied for a good few months. The disc has many articles on withdrawal and suicides - it's tough reading, particularly as I have endured the horrific side effects of withdrawal from that toxic drug of yours. It's particularly tough reading because of the suicide articles and papers too. I've also been privy to listen to heart wrenching stories from parents your drug paroxetine has had a hand in causing loss of life too. That irks me somewhat so you'll forgive me for rehashing this old Lancet article, I'm sure.

It was published in 1995, even back then you were denying there was a problem with your wonder drug.

You know, history has a way of catching up with you. It often bites you on the ass...pretty hard. [Cue Devil advocates to start muck spreading via their puppets and/or honey traps]

Two healthy white men, aged 36 and 48 years, participated in a controlled double-blind clinical trial of paroxetine treatment for stuttering. 

Both had a history of brief episodes of minor depression. 

After completing a 6- week treatment period with 50 mg paroxetine, both men went into a placebo phase. In the first case, 2 days after abrupt drug discontinuation, the subject reported hypomanic-like symptoms, including hyperactivity, decreased need for sleep, and irritability that developed into agitation, aggressiveness, and volatility. 

After 2 weeks of fluctuating symptoms, he experienced ego-dystonic impulsive behaviour such as shoplifting and suicidal impulses and gestures. All symptoms abated spontaneously after 2i weeks. 

In the second case, paroxetine was tapered over a 12-day period. The first week of withdrawal was notable for an uncharacteristic feeling of confidence and optimism, talkativeness, and a subjective feeling of sharpened and quickened thought processes. 

During the 2nd week, the patient developed physical symptoms of dizziness, blurred vision, nausea, lethargy, and insomnia. He also reported feeling angry,  irritable, and short-tempered, with some highly atypical explosive vocal outbursts and tantrums. He became preoccupied with homicidal thoughts and plans, initially directed towards acquaintances and later towards his own children. These became so intense and egodystonic that he contemplated suicide.

Physical and behavioural symptoms lasted about 9 days and then remitted spontaneously over 2-3 days.

In these two instances, men without a history of major psychiatric disorder developed severe behavioural symptoms when paroxetine was withdrawn. 

The first few days were characterised by predominantly hypomanic features followed by a period of escalated ego-dystonic aggression, behaviouraldyscontrol, and suicidal intention. This biphasic symptom pattern is reminiscent of the case of fluvoxamine precipitated withdrawal hypomania described by Szabadi.

We believe that the serious behavioural symptoms seen in these cases were adverse effects of paroxetine withdrawal.

Vol 346. July 1995 - The Lancet

GlaxoSmithKline, a leading healthcare company that helps people to do more, feel better and live longer.



Fid


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE

Dying for a Pfizer Pfag [Chantix]

Pharmaceutical giants Pfizer have hit the news...but not in the way they would like. Their anti-smoking cessation drug, Chantix, also known as Champix, is the subject of data being submitted through “improper channels” with regard to its safety and side effects.

Some 150 suicides, more than doubling those previously known, were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices, writes JoNel Aleccia, a health writer for msnbc.com.

This should come as no surprise for those that write about the pharmaceutical industry and the poor way in which prescription medication is regulated by the powers that be.

In 2008 the Federal Aviation Administration [FAA] took the unusual step of banning the use of varenicline [Champix] after it learned the anti-smoking medicine might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately. Strangely it is called Chantix in the USA.

The FAA took this action one week after a medical safety group, the Institute for Safe Medication Practices, released the results of a study that found evidence for the occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix.

Chantix was the subject of a freedom of information request I made back in April 2010. I had learned that the Federal Aviation Administration [FAA] had changed their policy regarding pilots being allowed to operate aircraft whilst under the influence of SSRi-type medication.

The FAA responded to my FOI in which I had requested the following:

1. Request for minutes of meetings where the change in the policy was on the agenda. List of members present and a declaration of interests of each of the members.

2. Any information given to FAA from outside parties that relate to the FAA'S recent change in policy regarding pilots on antidepressant medication.

3. A list of SSRi medications that pilots are NOT permitted to use and reasons why you think these SSRi's still pose a threat to safety.

4. A list of anti-smoking cessation drugs that pilots are NOT permitted to use and reasons why you think these still pose a threat to safety.

5. Does the FAA's new policy extend to air traffic controllers, if not, why?

6. An official statement from your CEO that categorically states that the FAA envisage that there will never be any incidents in the future with pilots that can be traced back to any adverse drug reaction from Prozac, Zoloft, Celexa and Lexapro.

Here's the cover letter of their response to me:

Mr. Bob Fiddaman,
Quinton
Birmingham
UK

Dear Mr. Fiddaman,

Re: Freedom of Iformation Act (FOIA) request 10-4122

This responds to your Freedom of Information Act email inquiry of April 6,2010 containing six requests concerning the FAA's recent change in policy regarding pilots being treated with certain select antidepressant medications. The FAA's policy regarding pilots with depression taking antidepressant medication may be found in the U.S. Federal Register Notice of April 5,2010 attached.

1. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. This office located a Memorandum report of a consultants meeting regarding the proposed policy. A copy of this Memorandum is attached. There are no other records respondent to your request.

2. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. This offrce located information received from the Aerospace Medical Association, the Airline Pilots Association Aeromedical Office, the International Airline Pilots Association, and the United States Army. Copies of these documents are attached. In developing the new policy, the FAA also utilized a variety of medical research literature available in the public domain. We used internet sites such as, but not limited to: The National Library of Medicine PubMed site and the FDA Medwatch.

3. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. There are no records responsive to this request. The four SSRI medications that will be considered for possible special issuance medical certifrcation are listed in the U.S. Federal Register Notice of April 5, 2010 attached.

4. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. There are no records responsive to this request. The only anti-smoking drug permitted for use while flying is nicotine in the form of gum or skin patches. All others are not allowed.

5. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. There are no records responsive to this request. The FAAs new policy does not presently apply to Air Traffic Control Specialist (ATCS) because the administrative details of the monitoring and follow-up of these employees are yet to be determined. The plan is that ATCSs will eventually be included in a program of this type.

6. This request does not apply under the Freedom of Information Act.

If you owe fees for the processing of this request, an invoice containing the amount due and payment instructions will be enclosed.

The accompanying 58 page document can be viewed HERE

This startling revelation by the FAA was obviously too much for me to handle so I sent the complete document along to investigative journalist, Evelyn Pringle. She, as with everything she writes, did it justice with an eye-opening article entitled, "SSRIs Render Unfriendly Skies"

One has to start asking questions regarding Pfizer's anti-smoking cessation drug. If the FAA deem it unacceptable for pilots to take this medication whilst operation an aircraft then they are sending out a crystal clear message - This drug is dangerous!

My only surprise is that the likes of Patrick McGorry, the Australian psychiatrist who plans to diagnose children as young as three for mental disorders they may get in the future, hasn't picked up on this particular cash-cow. Hey, Paddy, why not screen kids to see if they will smoke in the future? You could always nip it in the bud with a course of Pfizer's Champix.

The article from JoNel Aleccia, 'Smoking-pill suicides overlooked in missing reports', can be read in full HERE.

Pfizer has some questions to answer - don't hold your breath folks.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

US/CANADA COPIES HERE 
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